• Latin America the ‘Hidden Gem’ for First-in-Human Medical Device Trials

    Aug 14 | Clinical Research News | The big holdup in the development of advanced medical devices seems inevitably to happen at the point where first-in-human clinical trials are to begin, at least if the studies are to be conducted in the U.S. where it can be difficult to find clinical leaders, recruit patients, and bear the overall financial burden of their execution. More

  • Regulatory Proposals Good Match to Priorities of New FDA

    Aug 13 | Clinical Research News | Regardless of how one views the priorities of the Food and Drug Administration (FDA) under the new administration, it’s an opportunity for badly needed change to “shake things up,” according to Doug Bain, founder and consulting partner of UK-based ClinFlo, a newly launched consulting and service company focused on the application of technology to improve clinical research. More

  • How Non-Profits Are Contributing to the Clinical Research Landscape

    Aug 12 | Clinical Research News | The clinical research landscape is undergoing a significant transformation, with nonprofit organizations emerging as pivotal players in accelerating drug development for rare diseases. In the most recent episode of the Scope of Things podcast, Annette Bakker, CEO of the Children's Tumor Foundation (CTF), shared insights into how nonprofits are revolutionizing the clinical research ecosystem. More

  • Five Clinical Trends Shaping the Future of TMF Strategy

    Aug 08 | Clinical Research News | The trial master file (TMF) is the backbone of clinical trials, ensuring completeness of documentation and compliance for studies. Yet, TMF is still perceived as a file repository. Biopharma and CRO leaders are advancing their approach to make TMF a more strategic tool for study management and oversight. More

  • Fluorescence-Guided Surgery Shows Promise in Clinical Trials for Cancer Detection

    Aug 05 | Clinical Research News | Researchers are making significant strides in fluorescence-guided surgery, with dozens of glowing molecular probes currently under investigation in clinical trials to help surgeons better visualize tumor margins during operations. The technology could revolutionize surgical precision and eventually enable autonomous robotic surgery. More

  • The Evolving Role of the Clinical Data Manager

    Aug 01 | Clinical Research News | As gastrointestinal (GI) trials grow more sophisticated, the volume, velocity, and variety of study data have all expanded. One of the fastest-growing streams is electronic patient-reported outcomes (ePROs): diaries, symptom scores, quality-of-life surveys, and other instruments that come straight from the participant. Collecting this data quickly and conveniently is now mission critical. More

  • TrialX, ALS Network Partnership, Novel Multi-Cancer Detection Blood Test, More

    Jul 31 | Clinical Research News | TrialX has joined a partnership with the ALS Network; Fred Hutch Cancer Center has launched the Vanguard Study, a national study of a new type of blood test that screens several different cancers called multi-cancer detection (MCD) tests; and more. More

  • Follow the Money: Platform Creates Detailed Tumor Profiles, AI Helps with Clinical Trial Benchmarking, More

    Jul 30 | Clinical Research News | One Biosciences will further develop its OneMap platform, which creates detailed functional profiles of patient tumors that may help with optimizing clinical trials; Argon AI plans to expand their to build customized AI agents that can automate tasks, including clinical trial benchmarking; and more. More

  • The Connectivity Factor: How Interoperability, via AI Agents, Speeds Precision Medicine

    Jul 25 | Clinical Research News | What if trial timelines could be cut by years—just by improving how R&D systems and ecosystems talk to each other? In a recent study using generative AI (GAI) to aid decision-making from an integrated data ecosystem, trials sped up by more than 12 months. More

  • AI-Powered Cell Mapping Could Transform Precision Oncology and Accelerate Clinical Trials

    Jul 22 | Clinical Research News | Scientists at Virginia Commonwealth University (VCU) are tackling the massive computational problem of determining the distinct types of cells inhabiting biopsied tissue. Their endgame is to deploy a suite of interoperable artificial intelligence (AI) tools that can accurately and reliably guide prescribing decisions for patients with cancer as well as predict their response to investigational treatments prior to enrollment. More
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The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior writer Deborah Borfitz welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

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